Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2744-2011

Cambridge Endoscopic Autonomy Laparo-Angle 5mm Metzenbaum Scissors with Monopolar Cautery, 45 cm Catalog...

Cambridge Endoscopic Devices, Incorporated / initiated 2011-05-20 / Terminated / root cause: manufacturing process

Cambridge Endoscopic Devices, Incorporated began a recall of Cambridge Endoscopic Autonomy Laparo-Angle 5mm Metzenbaum Scissors with Monopolar Cautery, 45 cm Catalog Number: LA1101-12 Intended for use in a variety of... on . The reason FDA records is "PET shrink sleeve insulation material dislodging from the distal tips of Autonomy Laparo-Angle (ALA) Metzenbaum Scissors". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-2744-2011
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Cambridge Endoscopic Devices, Incorporated
Product
Cambridge Endoscopic Autonomy Laparo-Angle 5mm Metzenbaum Scissors with Monopolar Cautery, 45 cm Catalog Number: LA1101-12 Intended for use in a variety of minimally invasive procedures to facilitate grasping, mobilization, dissection, and transection of tissue.
Product code
GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall
PET shrink sleeve insulation material dislodging from the distal tips of Autonomy Laparo-Angle (ALA) Metzenbaum Scissors
Root cause tag
manufacturing process
FDA root cause
Process control
Action
Cambridge Endoscopic Devices, Inc. sent an "IMPORTANT MEDICAL DEVICE RECALL" letter dated May 20, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. Customers are instructed to return unused inventory using RGA Number 301. Returned devices will be replaced. Questions regarding this recall, call 508-405-0790 for assistance.
Quantity in commerce
255 units
Distribution
Worldwide Distribution--USA (nationwide) and the countries of Armenia , Australia, Austria, Chile, China, Denmark, Hong Kong, India, Ireland , Italy, Japan, Saudi Arabia, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey, and United Kingdom.
Product codes and lots
Lot Numbers: CB036695, CB036727, CB036932, CB036708, CB036931 CB037433